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Spine pain and joint pain are among the most common worldwide ailments and directly contributes to disability as well as increased duration of care. Spine and joint pain affect work sick leave, production and increased financial costs to healthcare. Non-invasive treatments for spine and joint pain can vary widely from lifestyle changes, physical therapy, oral medication, and select medical devices, that can improve pain level and help improve the quality of life of individuals. Thus, the general population suffers from an ailment that has multiple conservative treatment options with variable outcomes.
Transcutaneous Electrical Neuromuscular Stimulation (TENS) has been show to decrease pain and restore function. Interferential therapy (INF) is a specific signal type that is effective for reducing musculoskeletal pain. Neuromuscular Electrical Stimulation (NMES) uses a specific signal type to cause muscles to contract and therefore provide functional improvement. The RS-4i Plus is an FDA-regulated prescription TENS medical device that outputs an INF signal and a NMES signal, and a unique Intersperse signal, which combines NMES and INF into a single treatment. Therefore, the goal of this study is to determine if use of the prescribed RS-4i Plus in patients presenting with pain, axial or peripheral joint, can be efficacious in decreasing the patient's pain and improving their activity measured at one month, three months, and six months of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axial Spine only, Age 65+ |
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| Axial Spine only, Age 18-64 |
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| Peripheral Joint only, Age 65+ |
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| Peripheral Joint only, Age 18-64 |
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| Axial + Peripheral Joint, Age 65+ |
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| Axial + Peripheral Joint, Age 18-64 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RS-4i Plus | Device | RS-4i Plus in an FDA-regulated prescription TENS medical device that outputs and INF signal and a NMES signal and Intersperse signal, which combines INF and NMES into a single treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Pain / Function using NRS | Outcome with be rated on a scale of 0-10, in which 10 is the most severe pain / worst function and 0 is the least pain / best function. The time frame will include assessment at 1 month interval to determine if the intervention is showing a change / long term improvement in the pain / function | 1 month |
| Level of Pain / Function using NRS | Outcome with be rated on a scale of 0-10, in which 10 is the most severe pain / worst function and 0 is the least pain / best function. The time frame will include assessment at 3 month interval to determine if the intervention is showing a change / long term improvement in the pain / function | 3 month |
| Level of Pain / Function using NRS | Outcome with be rated on a scale of 0-10, in which 10 is the most severe pain / worst function and 0 is the least pain / best function. The time frame will include assessment at 6 month interval to determine if the intervention is showing a change or long term improvement in the pain / function | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be current adult patients of the UCI PM&R or Orthopedic Department
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Irvine Medical Center | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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